Quercetin In The Treatment Of SARS-COV 2

SARS (Severe Acute Respiratory Syndrome) Clinical Trial

— QUERCOV  

Official title:

Effectiveness of Quercetin In The Treatment of SARS-COV 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853199
• Other study ID #: QUERCOV
• Status: Completed
• Phase: Early Phase 1
• Start date: June 1, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: July 2023
• Source: Hôpital Universitaire Sahloul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In 1937, Albert Szent-Gyorgyi received a Nobel Prize for discovering vitamin C and flavonoids, as well as for exploring their biochemical properties. Originally, he gave the flavonoids the name "vitamin P" because of their effectiveness in reducing the permeability of blood vessels. This name was abandoned when it was realized that these substances were not really vitamins. Quercetin is extracted from a variety of plant sources, including the onion peel and the seeds and pods of Dimorphandra mollis, a legume tree native to South America. Although we are far from knowing everything about quercetin, its antioxidant, anti-inflammatory, and antihistamine (antiallergic) properties have been observed in numerous in vitro and animal studies.

Description:

Properties - Anti-oxidant, vascular protector - Inhibition of platelet aggregation, vasorelaxant , arterial relaxant - Anti-hypertensive , especially by certain derivatives (quercetin-3-glucuronic acid) - Nephroprotective in rats, protects against the nephrotoxicity of gentamicin - Anticancer , with immunostimulatory activity and inducer of apoptosis, with activity on the shock proteins HSP (heat shock proteins) hsp27 and hsp70 - Antitumor activity against prostate cancer and certain breast cancer cells - Prevention of cardiac toxicity from doxorubicin, with resveratrol - Protection against gastric inflammation associated with Helicobacter pylori infection by activity on MAPK, BCL-2, BAX. - Increases the antitoxic activity of the liver - Pancreatic lipase inhibitor, potential action in weight gain - Anti-inflammatory - Anti-allergic, inhibition of mast cell degranulation, with a preventive effect, reduction of inflammation linked to eosinophils (such as isoquercitrin regulates the Th1 / Th2 balance - Antiviral (dose-dependent reduction of infectivity, decreases intracellular replication) - Inhibition of rhinovirus replication - Influenza prophylaxis by quercetin or its derivatives (quercetin-3-O-α-L-rhamnopyranoside), opposes the pro-oxidant effects induced by the influenza virus, antioxidant therapy could be used to prevent serious complications associated with influenza - In vitro inhibition of the penetration of the Ebola virus by quercetin-3-O-glucoside - Antiviral activity against Zika virus, hepatitis B virus, hepatitis C, Epstein-Barr virus EBV and antitumor against human gastric carcinoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Clinical score greater than 6
• Patients with clinical symptoms less than 5 days old.
• Men and women at least 40 years old, able and willing to give informed consent;
• Any patient over the age of 18 with a CT scan in favor of COVID-19;
• Ambulatory or hospitalized environment;
• Patient with dyspnea or with a positive gait test;
• The patient must have at least one of the following high risk criteria: 70 years or older, obesity (BMI = 30 kg / m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure = 150 mm Hg), respiratory disease known (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary artery disease, fever = 38.4 ° C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia or a combination of a number high neutrophils and low lymphocytes count;
• The patient is not of childbearing age, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing age and uses at least one method of contraception and preferably two complementary forms of contraception comprising a method of barrier throughout the study and for 30 days after the end of the study;
• The patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

• • Patient currently in shock or exhibiting hemodynamic instability;
• Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption;
• Pregnant or breastfeeding patient
• Patient with a history of allergic reaction or significant sensitivity to Nigella;
• The patient is considered by the investigator, for whatever reason, to be an unsuitable candidate for the study.

Related Conditions & MeSH terms

• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Quercetin
Each patient should receive one tablet twice a day 30 minutes before the meal
• Placebo
Each placebo capsule contains 150 mg of microcrystalline cellulose and 1.5 mg of magnesium stearate.

Locations

Country	Name	City	State
Tunisia	Riadh Boukef	Sahloul	Sousse
Tunisia	HU Sahloul, sousse, Tunisia	Sousse	Itinéraire Ceinture Cité Sahloul

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Universitaire Sahloul

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	death rate	30 days
Primary	Need for ICU admission	Number of participants admitted to the Intensive care unit (ICU)	30 days
Primary	treatment safety	rate of adverse events	30 days
Secondary	Need for hospitalization for patients followed up at home	Need for hospitalization for patients followed up initially at home	30 days
Secondary	lenghth of stay in Hospital	days spent at hospital for patients followed up initially at home	30 days
Secondary	resolution of COVID-19 symptoms	Time to resolution of COVID-19 symptoms [ Evaluated at day 15 and day 30 precising the Time at which the patient is completely symptom free and severity of symptoms	30 days
Secondary	need for oxygen therapy	Number of participants who needed oxygen therapy	30 days